Study to Compare and Assess the Safety and Pharmacokinetic Characteristics After Oral Administration of Fimasartan (BR-A-657∙K) in Healthy Elderly and Young Male Volunteers

Boryung

Status and phase

Completed

Phase 1

Conditions

Essential Hypertension

Treatments

Drug: Fimasartan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00937534

A657-BR-CT-104

Details and patient eligibility

About

The purpose of this study is to compare and assess the safety and pharmacokinetic characteristics after oral administration of fimasartan (BR-A-657∙K) in healthy elderly and young male volunteers.

Full description

Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models.

Phase I study, Fimasartan (BR-A-657-K) 20 mg ~ 480 mg single dosing with healthy subjects, demonstrated that the Fimasartan (BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose.

A open-labeled, single-dosing, parallel Clinical Study to Evaluate pharmacokinetic characteristics after oral administration of fimasartan in healthy elderly and young male volunteers.

22 male healthy volunteers were enrolled during 2 months.

In part A, 240 mg of fimasartan per day was taken once by younger male healthy volunteers in day 1. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours after administration.

In part B, 240 mg of hydrochlorothiazide per day was taken once by elderly male healthy volunteers in day 1. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours after administration.

Enrollment

22 estimated patients

Sex

Male

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

age
- young: 19-45 years
- elderly: more than 65 years
sex: male
body weight: greater than 55 kg

Exclusion criteria

patients with contraindication to angiotensin II receptor antagonist.
patients with a history of liver, renal, gastrointestinal, hematological or cardiac diseases
patients with history or diseases which might affect absorption of the drug
patients with HIV, type B or C hepatitis
smokers of 20 or more cigarettes per day